Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of l. plantarum and p. acidilactici in children with upper respiratory tract infections

Conditions: Upper Respiratory Tract Infections; Pharyngitis; Tonsillitis

Summary: randomized, placebo-controlled trial to evaluate the coadjuvant effect of a combination of l. plantarum and p. acidilactici probiotic strains, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis. main objective is to evaluate efficacy of this probiotic in reducing fever and pain, as well to evaluate its safety.

randomized, placebo-controlled trial (rct) to evaluate the coadjuvant effect of probiotic strains l. plantarum cect30292, l.plantarum cect7484 and cect7485 together with p. acidilactici cect7483, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis, as diagnosed by a physician. main objective is to evaluate efficacy of this probiotic in reducing fever (as per infrared thermometer, same model for all recruited subjects) and pain (as per flacc scale \[face, legs, activity, cry and consolability\]), as well to evaluate its safety. secondary objectives include effect on cough, rhinorrhea, nasal congestion, use of concomitant medication, emergency visits, hospitalizations, schooling absences and salivary immune markers. probiotic intervention will last 15 days, and patients will return for follow-up visits on the last day of probiotic intervention (day 15), and well as day 30 and 60. the study aims at enrolling and randomizing 80 children fulfilling entry criteria and living in mexico city area (2,200m over the sea level), after parents or legal guardians sign informed consent.

Eligibility criteria:
inclusion criteria: * male and female children, 6 months to 5 years-old * diagnosed with upper respiratory tract infection with pharyngitis and/or tonsillitis by a physician * with fever \>37.5 celsius degrees and flacc (face, legs, activity, cry and consolability) score \>3 * symptom onset no more than 48h before study entry * body weight at birth \>2500 gr * informed consent provided by parents or legal guardians exclusion criteria: * failure to thrive * asthma or significant allergic disease * use of antibiotics, antivirals, probiotics or prebiotics for more than 48h within 2 weeks of study entry * history of recurrent respiratory infections (\>2 otitis, \>1 severe sinusitis or \>1 pneumonia) within 12 months of study entry * history of 2 or more invasive infections (meningitis, cellulitis, osteomyelitis, sepsis) * chronic diarrhea or short bowel syndrome * congenital heart or respiratory deficiency * known alpha1-antitrypsin deficiency * concurrent participation in other clinical trial(s) * other particular conditions which, in the judgment of the principal investigator, may interfere with the study

Keywords: probiotic
repeatability of oct and iv-us in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: to assess the correlation between pulmonary iv-oct and pulmonary iv-us measurements and standard pah clinical measures of disease progression and the relative sensitivity of the techniques to change.


Eligibility criteria:
inclusion criteria: * with confirmed diagnosis of pah group 1 according to the esc/ers guidelines * with severe disease, defined as class ii- iii of the modified who functional classes in the esc/ers guidelines exclusion criteria: * that according to investigator criteria cannot participate in the trial
a drug-drug interaction (ddi) study to assess the effect of inc280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cmet-dysregulated advanced solid tumors

Conditions: cMET-dysregulated Advanced Solid Tumors

Summary: the study aim to assess the effect of inc280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cmet-dysregulated advanced solid tumors


Eligibility criteria:
inclusion criteria: patients must have: * advanced solid tumors and have confirmed cmet dysregulation * at least one measurable lesion as defined by recist 1.1. * recovered from all toxicities related to prior anti-cancer therapies * adequate organ function * ecog performance status (ps) of 0 or 1 exclusion criteria: patients must not have: * known hypersensitivity to any of the excipients of inc280 * prior treatment with cmet or hgf-targeting inhibitor * known hypersensitivity to digoxin or rosuvastatin or its excipients * symptomatic central nervous system (cns) metastases who are neurologically unstable * presence or history of carcinomatous meningitis * history of another primary malignancy that is currently clinically significant or currently requires active intervention * clinically significant, uncontrolled heart diseases, including qtcf ≥ 450 msec (male patients), ≥ 460 msec (female patients) on the screening ecg * thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting inc280 * major surgery within 4 weeks prior to starting inc280 * patients receiving unstable or increasing doses of corticosteroids. * impairment of gi function or gi disease that may significantly alter the absorption of inc280 * patients who have received, or are expected to receive digoxin or rosuvastatin within 21 days prior to the beginning of the ddi phase (day 1) and for the duration of the ddi phase. other protocol-defined inclusion/exclusion criteria may apply

Keywords: cmet, inc280, rosuvastatin, digoxin
the objective is to respond to patients' needs in the field of larynx replacement

Conditions: Swallowing Disorders; Dysphagia; Laryngeal Neoplasms

Summary: supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. the secondary objective is to study the concept of a special valves system for the development of an artificial larynx


Eligibility criteria:
inclusion criteria: * age more than 18 * swallowing troubles exclusion criteria: * pregnant women * contraindications to general anesthesia

Keywords: larynx, tracheotomy, titanium beads
a digital therapeutic platform for swallowing and drooling problems in parkinson's

Conditions: Dysphagia; Parkinson Disease

Summary: the purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with pd.

the project goal is the development and early stage validation of a wearable sensor for dysphagia in patients with pd. the first phase of the program involves engineering goals relating to increasing the battery life of this sensor to 48 hours between charges and reducing the overall form factor size. the second phase of the program is to conduct focus groups with pd patients to assess sensor usability, set up burden, and design feedback. the third phase of the study will assess the feasibility of the sensor to detect and cue swallowing in a small cohort of pd patients.

Eligibility criteria:
inclusion criteria. age ≥22. english speaking. diagnosis of idiopathic parkinson's disease of any hoehn and yahr stage (i-v), determined by a neurologist. mild to moderate sialorrhea defined as a score of ≥ 11\* on the radboud oral motor inventory for parkinson's disease (romp)-saliva (c) subscale subjects must be in the "on" phase of their medication during all study assessments. the "on" phase is defined as the period when the participant's medication is at peak effectiveness, minimizing motor fluctuations and enabling optimal motor function. study exclusion criteria. history of aspiration pneumonia within the past 12 months. unable to swallow saliva without a maneuver. actively receiving treatment for swallowing disorders or sialorrhea. current alcohol/drug abuse. diagnosed with neurological disorders other than pd. end stage dementia. history of head and neck cancer or surgery. unable to demonstrate competency with the user-friendly sensor platform technology. known allergy to contrast material used during mbss. known allergy to sensor adhesive. indwelling tracheostomy tube. nasogastric (ng) feeding tube. currently pregnant.
scalp pruritus measurement using visual analog scale and 5-d itch scale in children with pediculosis capitis

Conditions: Pediculus Capitis; Pruritus

Summary: pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of life disturbances. there are two objective measurement for pruritus, visual analog scale (vas) and 5-d itch scale, which can assess the severity of the scalp pruritus and the latter can also asses the quality of life affected by pruritus. even though vas can not be used to evaluate the impact of pruritus on quality of life, it is very easy to use while 5-d itch scale is complex and not child-friendly. the aim of this study is to determine the relationship between two different pruritus scales and to establish validity of pruritus vas scale in evaluating quality of life in children with pediculosis capitis. we compare two pruritus scale on students with pediculosis of two boarding school in bogor, west java, indonesia.

this study used cross sectional design study. subjects with eligible criteria were included and informed consent from the parents or legal guardian were obtained. the diagnosis of pediculosis capitis was made based on the findings of eggs, larva, or an adult parasite on the scalp or in the hair of the students. all subjects were asked for both vas and 5-d itch scale.the vas is categorized into five groups based on the point, as follows: 0 for no pruritus, \<3 for mild pruritus, ≥ 3 - \<7 for moderate pruritus, ≥ 7 - \<9 for severe pruritus, and ≥ 9 for very severe pruritus. the 5-d itch scale consists of five parameters: duration, degree, direction, disability (sleep, leisure/social activities, housework/errands, work/school), and distribution of the pruritus with points ranging from one to five. data were recorded for statistical analysis, a chi-square test was used to determine the relationship between two categorical variables. the correlation coefficient between the vas and 5-d itch scale was calculated using spearman's rank correlation

Eligibility criteria:
inclusion criteria: * students studying in junior high school at boarding school in bogor with medium length hair who were clinically diagnosed with pediculosis capitis * willingness to participate as a research subject (to be interviewed and undergo physical examination), and after being explained the details of the study, granted the headmaster permission to sign consent in their name (informed assent) exclusion criteria: * chemical treatment of pc within 10 days before the trial * history of permethrin hypersensitivity * unwillingness to participate as a research subject * mild-to-severe secondary infection * long or short hair

Keywords: pediculosis capitis scalp pruritus vas scale 5-d itch scale quality of life
study of difluprednate vs. prednisolone acetate on visual acuity, and corneal edema following cataract surgery.

Conditions: Cataracts; Corneal Edema; Retinal Structural Change, Deposit and Degeneration; Visual Acuity Reduced Transiently

Summary: the purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.


Eligibility criteria:
inclusion criteria: * healthy male or female 21 years of age or older * scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries. * willing and able to administer eye drops and record the times the drops were instilled * understand and are willing to sign the informed consent form * willing to complete the entire course of the study. exclusion criteria: * use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery. * known sensitivity to any of the ingredients in the study medications or similar medications. * scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart. * corneal edema in either eye. * need for regional or general anesthesia during surgery. * complicated cataract surgery, including use of iris hooks or iris stretchers. * sight better than 20/100 in only one eye. * a history of previous intraocular surgery in either eye. * a history of uveitis, iritis, or intraocular inflammation. * macular pathology of the retina. * presence of glaucoma. * any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease. * history of steroid-related intraocular pressure (iop) rise in the study eye. * lack of an intact corneal epithelium. * pupils that do not dilate to more than 5 mm prior to surgery or you require mechanical stretching of your pupil. * diabetes mellitus. * required use of a systemic steroidal or non-steroidal anti-inflammatory during the study period. * doctor has determined the presence of a condition (i.e., uncontrolled systemic disease) or a situation that may put the subject at significant risk, confound the study results or may interfere significantly with your participation in the study. * females, who are pregnant, nursing an infant or planning a pregnancy. * currently involved in another investigational study or have participated in one within the 30 days prior to entering this study. * unable or unwilling to give signed informed consent prior to participation in any study-related procedures.

Keywords: cataract surgery, vision, corneal edema, retinal thickness
nonpharmacologic pain management in fqhc primary care clinics

Conditions: Low Back Pain; Chronic Pain

Summary: the goal of this study is to improve pain management and reduce opioid reliance for patients with chronic back pain in utah federally-qualified health centers (fqhcs). the study compares the effectiveness of nonpharmacologic pain treatments using telehealth to overcome access barriers. we will use automated ehr reminders for electronic referral to teleconsult services. our project tests adaptive treatments and uses a hybrid type i design - focused on effectiveness outcomes while gathering implementation data to inform future efforts to scale effective strategies.

this randomized clinical trial compares the effectiveness of different strategies to provide efficacious nonpharmacologic interventions to patients with back pain seeking care in fqhcs throughout the state of utah. the strategies evaluated are designed to overcome the barriers specific to rural and low income communities served by fqhc clinics through innovative use of telehealth resources. the randomized trial will randomize individual participants to one of two interventions strategies, one providing both a brief pain teleconsult with a 10-week telehealth physical therapy, the other uses an adaptive strategy - providing the brief pain teleconsult first, followed by the 10-week telehealth physical therapy only among those non-responsive to the brief teleconsult treatment. we will also evaluate outcomes related to the efforts to implement strategies in fqhc clinics in order to provide valuable information for future efforts to scale effective strategies into other low resource health care settings. assessments will occur at baseline and after 12-, 26- and 52-weeks.

Eligibility criteria:
inclusion criteria: * able to communicate in english or spanish * age between 18-80 * visit with an fqhc provider (in-person or via telehealth) in past 90 days * back pain has been an ongoing problem for at least the past 3 months, and has been a problem on at least half the days in the past 6 months * access to resources necessary to receive telehealth sessions (phone or 2-way video) exclusion criteria: * currently pregnant * currently involved in active substance use disorder treatment (other than peer support groups, aa, etc.) * history of spine surgery in past 6 months * has a condition restricting participation in physical activity (i.e., unable to ambulate independently (with or without assistive device) for at least 5 minutes. * reason for back pain is a fracture or non-musculoskeletal condition (i.e., spinal tumor, inflammatory disorder, etc.)

Keywords: telehealth pain management physical therapy health disparities
psycho-oncological intervention through counselling in patients with differentiated thyroid cancer in treatment with radioiodine

Conditions: Thyroid Cancer

Summary: diagnosis and treatment of differentiated thyroid carcinomas cause anxiety and depression. additionally, these patients suffer hormonal alterations, associated with psychological symptoms (changes in mood, emotional instability, memory loss, etc.). this study aims to evaluate the effectiveness of a psycho-oncological intervention based on counselling to reduce anxiety and depression related with the treatment in patients with differentiated thyroid carcinomas.

a non-randomized controlled study, with two groups (experimental, n=37, and control, n=38) and baseline and post-treatment measures was designed. patients in experimental group received a psycho-oncological intervention based on counselling in addition to the standard treatment. the independent variable was the assigned group and the dependent one was the evolution of anxiety and depression, analyzed separately, both evaluated using hads. other relevant covariables related with quality of life were also analyzed using sf-36 and pgwbi scales.

Eligibility criteria:
inclusion criteria: * patients diagnosed with dtc (differentiated thyroid carcinoma) * initial treatment by total thyroidectomy * treatment with rit after physiological stimulation of thyroid-stimulating hormone (tsh) by suppression of hormone replacement therapy (hrt) for a month * fluid spanish speaker * 18 years or over * obtaining informed consent exclusion criteria: * diagnosis or treatment for psychiatric disorders * any type of illness with serious impact in medical condition * inability to communicate or to process the information

Keywords: cancer oncology psycho-oncology psychotherapy thyroid cancer radioisotope therapy quality of life
the effect of the treatment environment on pain, function, self efficacy and satisfaction in rcrsp

Conditions: Shoulder Pain; Subacromial Pain Syndrome; Rotator Cuff Syndrome of Shoulder and Allied Disorders

Summary: brief summary the aim of this randomized controlled study is to reveal the short-term effects of physical and social factors in different therapeutic environments on patients with rotator cuff related shoulder pain following the same exercise program. the main questions it aims answer are: * is there any difference in terms of pain levels among groups with rotator cuff related shoulder pain who treated in different therapeutic settings. * is there any difference in terms of functionality and self-efficacy among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.

the investigators will include patients who applied to the physiotherapy clinic of kadikoy florence nightingale medical center with the complaint of shoulder pain. 46 individuals who volunteer to participate in the study will be included. participants will be randomised through a computer-based randomization program into two groups; the enriched therapeutic environment group (group 1) and the isolated therapeutic environment group (group 2). the same treatment including patient education, exercise therapy and ice application will be performed to both groups. participants will receive a total of 15 sessions of treatment, 3 sessions per week. before the treatment, 3rd week, 6th week and 12th week, the following evaluations will be made to both groups; numerical pain rating scale (nprs) to asses pain, arm, shoulder, hand problems quick survey (quick-dash) and western ontario rotator cuff index (worc) to asses functionality, pain self-efficacy questionnaire (pseq) to asses self efficacy and global scale of change (grc) to asses the effectiveness of the treatment.

Eligibility criteria:
inclusion criteria: * 18-75 years old * diagnosed with impingement syndrome, subacromial bursitis, rotator cuff tendinopathy or partial rotator cuff tear * pain level between 3-7 according to visual analog scale * pain persisted for at least 3 months exclusion criteria: * having a full-thickness or massive rotator cuff tear * history of shoulder surgery * having a musculoskeletal disease that prevents exercise * having a neurological disease or psychological disorder

Keywords: therapeutic environment contextual factors exercise therapy
randomized controlled study of postoperative adjuvant therapy for gastric cancer using ts-1 or ts-1+psk

Conditions: Gastric Cancer

Summary: a randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of ts-1 alone or psk combined with ts-1, with the objective to examine or validate the outcome, qol and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of ts-1.

the 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages ii, iiia, iiib and iv. tegafur-gimeracil-oteracil potassium (ts-1) is used as the first line treatment for advanced and recurrent gastric cancer. but ts-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines. among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer, the beneficial results of survival rates using krestin (psk) in combination with chemotherapy have been reported. with the objective to enhance the antitumor effect of ts-1 and to improve the qol of patients, we have planned to validate the clinical significance of combined psk and ts-1 therapy as postoperative adjuvant therapy for gastric cancer, using in principle the ts-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months.

Eligibility criteria:
inclusion criteria: * patients with microscopic stage ii or iiia resectable gastric cancer * patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy) * patients with serum immunosuppressive acidic protein (iap) measured within 2 weeks before surgery * patients with no metachronous or synchronous multiple cancer * patients without severe impairment of renal, hepatic and bone marrow functions * patients who are judged to be capable of tolerating surgery * patients with preoperative performance status 0 to 2 * patients with no serious concurrent complications (such as bone marrow suppression, diarrhea and infection) * patients who are judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study exclusion criteria: * patients with fresh hemorrhage from the gastrointestinal tract * patients with retention of body fluid necessitating treatment * patients with infection, intestinal palsy or intestinal occlusion * patients who are pregnant or hope to become pregnant during the study period * patients with diabetes treated by continuous use of insulin or showing poor glycemic control * patients with a history of ischemic heart disease * patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study * patients receiving continuous administration of steroids * patients who have experienced serious drug allergy in the past * others, patients judged by the investigator or subinvestigator to be inappropriate as subject

Keywords: gastric cancer ts-1 psk disease-free survival overall survival